Pfizer needs more data for COVID-19 booster shot approval, US regulators say

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U.S. scientists and regulators told Pfizer July 12 that they need more data and more time to determine if COVID-19 vaccine booster shots are necessary, The New York Times reported. 

Pfizer representatives met with senior U.S. officials to discuss FDA approval of a third COVID-19 shot. The officials said it could take several more months to determine if booster shots will be necessary. 

Pfizer is gathering information on the antibody responses of people who've received a third dose and plans to submit at least some of it to the FDA in the coming weeks in a request to broaden its emergency use authorization, according to the Times

Experts, including Anthony Fauci, MD, President Joe Biden's chief medical adviser, have said there's not enough evidence at this time that boosters are needed, the Times reported. They also said the final decision on booster shots will depend on real-world information gathered by the CDC on breakthrough infections that cause serious disease and hospitalization. 

If booster shots are authorized, they will likely be targeted to specific groups, such as the elderly, who were vaccinated in late 2020 or early 2021, the Times reported. It's unclear if the booster would be a third dose of the original vaccine or a shot tailored to a specific variant, such as the delta variant, which is spreading rapidly in the U.S

The HHS released a statement after the meeting with Pfizer, saying: "At this time, fully vaccinated Americans do not need a booster shot," according to the Times

Carlos del Rio, MD, an infectious disease expert at Emory University in Atlanta, told the Times: "At this point, the most important booster we need is to get people vaccinated."

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